A Diagnostics & Imaging Week
DxTech (Merrimack, New Hampshire), developing technology aimed at putting diagnostic information in the hands of physicians in real time, said it has entered into a long-term strategic alliance with Nicholas Piramal India (NPIL), described as one of the largest pharmaceutical and healthcare companies in that country.
The alliance includes a license and development, a distribution agreement and an agreement to establish a joint venture between the companies for the marketing and sales of the commercial product emerging from DxTech's technology.
DxTech is developing the Vantix point-of-care (POC) diagnostics platform, based on electrochemical sensor technology that it said has "unparalleled sensitivity and dynamic range."
The company said it will bring "two points of differentiation to the POC market that cannot be realized by any other POC technology currently available: the capability to conduct simultaneous diagnostic immunoassays and general chemistries on a single cartridge delivering a uniquely broad range of tests."
In addition to its core focus on the $48 billion routine diagnostic market in the U.S., DxTech said the Vantix platform has the added potential to transform diagnostic testing in a range of other emerging markets, including Asia, parts of Europe, and Central and Latin America.
In these markets, the company said the Vantix platform "could reduce or eliminate the need for expensive, centralized laboratory infrastructures and replace them with equally accurate testing that has a more favorable cost profile, distributed across each point of care."
DxTech said the Vantix platform is designed to "meet or exceed the performance levels established by U.S. reference laboratories, to provide a complete solution from sample collection through claims processing, to be CLIA-waivable, to provide a strong gross margin in the U.S. market and, at the same time, to be economically viable in developing countries."
Assay and instrument development is being conducted at the company's facility in New Hampshire, while manufacturing of the proprietary sensor is being done at its facility in Cambridge, UK.
The alliance gives NPIL an exclusive license to the Vantix platform in India, Pakistan, Bangladesh, Sri Lanka, Nepal and Bhutan.
In return, DxTech has received what it said is "a multi-million dollar up-front fee" and will receive three additional product development fees, based on specific milestones over the next 18 to 36 months, each for at least $1 million. DxTech also will receive long-term royalties based on gross sales in India, as well as its share of profits made by the joint venture.
CE mark for BD's VanR assay
BD Diagnostics, a unit of BD (Becton, Dickinson and Co.; Franklin Hills, New Jersey), reported the CE-marking of the BD GeneOhm VanR assay for the rapid detection of vanA and vanB genes, which are associated with vancomycin-resistant Enterococci (VRE).
BD said it would immediately begin commercializing the new assay throughout Europe.
The company said that VRE-associated infections have a high attributable mortality rate and are associated with excess costs and length of stay. According to BD, VRE prevalence in healthcare facilities has increased steadily since it was first reported in 1987 and now accounts for about 30% of enterococcal infections in intensive care unit patients in the U.S. In Europe, the majority of countries report vancomycin-resistance rates ranging from 25% to 50% of enterococcal isolates.
The BD GeneOhm VanR assay is a qualitative in vitro polymerase chain reaction (PCR) test for the detection of vancomycin-resistant genes directly from perianal and rectal swabs.
The first CE-marked molecular assay to directly test clinical specimens, the test allows hospitals and reference laboratories to identify patients colonized with the resistant organisms associated with VRE in as little as two hours. Conventional culture-based microbiology algorithms require three to four days to produce definitive test results.
BD said the new test will help enable earlier implementation of infection control measures to prevent VRE transmission and infection, leading to decreased length of stay and reduced healthcare costs.
Clinical-trials firm adds DEXA scanners
Synexus (Manchester, UK) said it has "significantly increased" its capacity to recruit and run global osteoporosis trials by increasing the number of DEXA scanners at its hub sites by a third. The DEXA scan is widely believed to be the most reliable way of identifying osteoporosis and is the best test for measuring bone mineral density.
The company said it has complemented its DEXA investment with the provision of heel scanners to hundreds of primary care practices to boost enrollment.
Osteoporosis affects one in three women over 50 and one in five men around the world; increasing to one in two and one in three in the over 60s. It is estimated that the worldwide cost of osteoporosis will increase to $131.5 billion by 2050.
Ian Smith, MD, medical director and founder of Synexus, said, "The heel scan is a quick, easy and cost-effective way of determining whether there is a likelihood of osteoporosis. All the patients who have an elevated reading are then offered a DEXA scan at one of our hub sites in order to make a definitive diagnosis."
CEO Michael Fort added, "We have dramatically increased our capacity in the area of osteoporosis due to demand from our clients. With our network of 14 clinics in the UK, Eastern Europe, South Africa and India, we are able to randomize thousands of patients."
Synexus recruits participants for clinical trials on behalf of pharmaceutical, biotech and contract research organizations. The clinical trials are then run and managed by Synexus at 14 hub sites across the UK, Poland, Hungary, Bulgaria, India and South Africa.
Swiss firm gets additional funding
Solianis Monitoring (Zurich, Switzerland) said Zürich Cantonal Bank will invest in the company's efforts to develop a non-invasive glucose monitoring device.
Together with a research grant from the European Union and private investors, a total of CHF 2.5 million has been raised.
Solianis said the Zürich Cantonal Bank will participate with CHF 500,000 as a part of its funding program for pioneer companies. "It is essential for us to support start-ups in the difficult fundraising process and be a reliable partner for the development of the company," said Herbert Huwiler of the bank's Start-up Finance unit.
In addition, the Seventh Framework program for research and technological development, the main instrument of the EU to fund European research, supports the company with €220,000 to continue its activities.
Solianis Monitoring CEO Mario Stark said, "With this capital increase we can continue the current clinical work to demonstrate that our technology is applicable in the daily life of patients."